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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD DRIVE; BATH SAFETY
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NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD DRIVE; BATH SAFETY Back to Search Results
Model Number BRTL12606-AST
Device Problem Fracture (1260)
Patient Problems Bruise/Contusion (1754); Fall (1848)
Event Date 08/31/2019
Event Type  Injury  
Event Description
Drive devilbiss healthcare is the initial importer of the device which is a bath bench.The end-user is unwilling to return the device.We will be unable to evaluate for root cause.End-user was sitting on the device in the shower.It cracked and she fell.Emts and fire department personnel had to assist her in getting up.She did not seek medical attention.She was sore and bruised after incident.End-user hit her head on the shower.She had a bump on her head.We are filing this report in an overabundance of caution due to the head injury.
 
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Brand Name
DRIVE
Type of Device
BATH SAFETY
Manufacturer (Section D)
NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD
west of tanjialing road
yuyao zhejiang,
31540 8
CH  315408
MDR Report Key9447907
MDR Text Key176298014
Report Number2438477-2019-00081
Device Sequence Number1
Product Code ILS
UDI-Device Identifier00822383927305
UDI-Public822383927305
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberBRTL12606-AST
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/10/2019
Distributor Facility Aware Date09/23/2019
Event Location Home
Date Report to Manufacturer12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight113
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